MicroPort® CRM receives CE mark for TALENTIA and ENERGYA, ICDs and CRT-Ds, featuring Bluetooth connectivity alongside an advanced programmer user interface

Clamart, France, January 23, 2024 – MicroPort® CRM, a pioneering company in the field of Cardiac Rhythm Management, headquartered in France, recently received dual CE mark approvals under the new Medical Device Regulation (MDR – 2017/745) for TALENTIA™ and ENERGYA™, their new range of Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy and Defibrillation devices (CRT-Ds) and their programmer user interface.

TALENTIA™ and ENERGYA™ ranges enable wireless communication via Bluetooth®, allowing for tablet-based programming and remote monitoring. The devices are provided with a smart home monitor, SMARTVIEW CONNECT™ to be placed at the patient’s bedside. The monitor allows healthcare professionals to receive detailed reports automatically and regularly on the functioning of the system, as well as timely alerts and transmissions triggered by the patients when they have symptoms.

These devices also feature the PARAD+™ arrhythmia discrimination algorithm with the clinically proven lowest rate of inappropriate shocks1, and AutoMRI™, a function that automatically switches the device into a specific mode to protect patients during Magnetic Resonance Imaging (MRI) examinations2. These devices are also approved for 1.5 Tesla (T) and 3T MRI compatibility.

SonR®, a unique hemodynamic sensor measuring the contractility of the left ventricle is a MicroPort exclusivity available on TALENTIA™ CRT-D SonR. The SonR® system is the first and only CRT hemodynamic sensor designed to automatically optimize patients every week and, more importantly, while the patient is active, providing real-life optimization. The clinically proven SonR® algorithm has demonstrated a 35% risk reduction in heart failure hospitalization.3

“The latest technology in ICDs and CRT-Ds combined with a modern and intuitive programmer user interface make MicroPort® CRM a strong driver on the market” stated Benoît Clinchamps, President of MicroPort® CRM, “the integration of Bluetooth Low Energy technology for wireless and remote monitoring in both pacemakers and defibrillators devices reinforce our commitment to advancing connectivity and enhancing user experience”.

Combined with the release of TALENTIA™ and ENERGYA™ ranges, MicroPort® CRM launches a new user interface dedicated to their ICDs and CRT-Ds. The very modern “look and feel” interface perfectly suits to their SMARTTOUCH™ tablet programmer.

In addition, MicroPort® CRM ICDs and CRT-Ds devices incorporate advanced technology with low current consumption, resulting in no compromise on the device longevity. TALENTIA™ and ENERGYA™ with the world's greatest projected longevity make them the longest-lasting defibrillators on the market.4,5

About Implantable Cardiac Defibrillators (ICDs):

Implantable Cardiac Defibrillators (ICDs) are for use in patients with a high risk of sudden cardiac death, continuously monitoring the heart rate and helping to regulate fast and potentially life-threatening electrical problems with the heart. ICDs are connected to the heart by one or two leads, including a defibrillation lead that passes through the veins. ICDs provide pacing bursts to stop sustained ventricular tachycardia (fast heart rate), as well as ‘back up’ pacing in case of bradycardia (slow heart rate). They also deliver high-energy shocks through the defibrillation lead to restore a normal rhythm within seconds when the electrical activity of the heart deteriorates into ventricular fibrillation.

About Cardiac Resynchronization Therapy (CRT)

CRT therapy is indicated in heart failure patients with cardiac desynchronization. The CRT devices are implanted under the skin, in the chest area, and are connected to the heart by three transvenous pacing leads that conduct electrical impulses to pace the heart. The pacing leads are positioned in the right atrium, right ventricle and left ventricle. The electric stimulation of the cardiac chambers triggering their contractions is synchronized in order to restore a better pumping efficiency of the heart. The CRT therapy has been demonstrated to improve survival and quality of life, and to reduce hospitalization in heart failure patients.6

About MicroPort® CRM:

MicroPort® CRM is a pioneering company in the field of Cardiac Rhythm Management (CRM) and a subsidiary of MicroPort Scientific Corporation (stock code: 00853.HK), with world headquarters in Clamart, near Paris, France. Drawing on its extensive expertise in CRM, MicroPort® CRM develops, manufactures, and markets cardiac pacemakers, implantable cardiac defibrillators, cardiac resynchronization systems, and ECG diagnostic solutions for managing cardiac rhythm disorders and heart failure globally.

For more information, please visit www.microport.com.


References:

1.Dichtl W. et al., Low rates of inappropriate shocks in contemporary real-world implantable cardioverter defibrillator patients: the CARAT observational study. EP Europace, Volume 25, Issue 9, September 2023, euad186, https://doi.org/10.1093/europace/euad186

2. MicroPort CRM MRI Solutions Manuals available online at microportmanuals.com

3. Brugada J., et al. Contractility sensor-guided optimization of cardiac resynchronization therapy: results from the RESPOND-CRT trial. Eur. Heart J 2017; 38(10):730-8

4. Refer to user manual supplied with the device for complete instructions for use

5. Munawar DA et al. Predicted longevity of contemporary cardiac implantable electronic devices: A call for industry-wide "standardized" reporting. Heart Rhythm. 2018 Dec;15(12):1756-1763.

6. Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J. Cardiac resynchronization in chronic heart failure. N Engl J Med 2002;346:1845–1853.